- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00721344
A Study to Determine if Technosphere® Inhalation Powder (FDKP) Causes ECG Changes (QTc) Following the Medication's Inhaled Administration.
June 12, 2012 updated by: Mannkind Corporation
A Phase 1, Randomized, Double-Blind, Cross-Over, Placebo- and Active-Controlled Cardiac Safety Study of Therapeutic and Supratherapeutic Doses of Fumaryl Diketopiperazine Administered as Technosphere® Inhalation Powder in Healthy Subjects
48 healthy adult male & female subjects will be enrolled in this study to determine the effect of Technosphere® Inhalation Powder (FDKP) on the QT interval of the EKG.
Eligible subjects will be randomized into a dosing regimen after admission.
Study Overview
Status
Completed
Conditions
Detailed Description
This is a Phase 1, randomized, double-blind, cross-over, placebo- and active-controlled cardiac safety study in 48 healthy subjects (both male and female subjects) designed to assess the effect of FDKP on cardiac repolarization, if any, following introduction of Technosphere® Inhalation Powder via inhalation.
Each trial subject will be administered 20 mg of FDKP, 40 mg of FDKP, 400 mg oral dose of moxifloxacin (active), and placebo in a crossover design during an 11 day in-patient stay.
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Tacoma, Washington, United States, 98418
- Charles River Clinical Services Northwest
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Pulmonary Function Tests (PFTs) results within study specified limits.
- Female subjects of childbearing potential must be non-pregnant and non-lactating and have a negative serum pregnancy test prior to enrollment into the trial.
- Body Mass Index = 19 and = 30 kg/m2
- Absence of recent drug or alcohol abuse
- Able to provide written informed consent, follow study procedures and remain in-patient for the entire treatment period
- Non-smoking (> 6 months)
Exclusion Criteria:
- History of significant renal, pulmonary, rheumatological, hematological, neurological or psychiatrics disorder
- Clinically significant major organ disease
- Evidence or history of clinically significant allergies (except for untreated, asymptomatic, seasonal allergies at time of dosing);
- Current or previous chemotherapy or radiation therapy that could cause lung toxicity
- History of diabetes or taking any medications to treat diabetes
- Clinically significant abnormal findings on physical exam, ECG, vital signs, clinical laboratory testing and medical history
- Hypokalemia (calcium below lower limit of normal).
- Previous exposure to Technosphere® Inhalation Powder
- Participation in another clinical trial of an investigational drug or device within 30 days prior to Visit 3
- Significantly excessive consumption of food or beverages with xanthine or caffeine
- Unwilling to avoid alcohol 48 hours prior to study enrollment and during study
- Unwilling to avoid strenuous activity for 48 hours prior to study enrollment and during study
- Positive HIV or Hepatitis test
- Any acute illness or fever within 72 hours of study dosing
- Medication use (with exception of acetaminophen and hormonal birth control) or herbal use within 7 days of Visit 2
- Unwillingness to remain in a quiet, controlled environment (i.e., no TV, music, games, etc during specific timepoints) or unwilling to remain supine during specific timepoints
- Unwillingness to consume a study-specific diet
- Blood donation within 8 weeks prior to Visit 2
- History of chronic obstructive pulmonary disease (COPD), clinically proven asthma and/or any other clinically important pulmonary disease confirmed by pulmonary function testing and/or radiological finding
- Active respiratory infection or persistent symptoms of such infection
- History of risk factors for Torsades de pointes (TdP) [e.g., heart failure, hypokalemia, family history (parents or siblings) of Long QT Syndrome], history of fainting, unexplained loss of consciousness or convulsions
- History of cardiac arrhythmia, of taking anti-arrhythmia drugs, significant cardiovascular dysfunction, myocardial dysfunction, cardiac surgery, transient attacks of ischemia or cerebrovascular accidents
- An abnormal screening ECG which is interpreted by the Clinical Site Investigator to be clinically significant
- Sustained supine resting systolic blood pressure > 140 mm Hg or < 100 mm Hg and /or diastolic blood pressure >95 mm Hg at study entry Baseline pulse rate of < 45 beats per minute or > 100 beats per minute
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
|
Technosphere® Inhalation Powder 20mg
Tablets 400mg
Technosphere® Inhalation Powder 40mg
Placebo cartridges
|
EXPERIMENTAL: 2
|
Technosphere® Inhalation Powder 20mg
Tablets 400mg
Technosphere® Inhalation Powder 40mg
Placebo cartridges
|
EXPERIMENTAL: 3
|
Technosphere® Inhalation Powder 20mg
Tablets 400mg
Technosphere® Inhalation Powder 40mg
Placebo cartridges
|
EXPERIMENTAL: 4
|
Technosphere® Inhalation Powder 20mg
Tablets 400mg
Technosphere® Inhalation Powder 40mg
Placebo cartridges
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary endpoint is the time-matched, placebo-subtracted change from baseline in QTc after a supratherapeutic dose of Technosphere Inhalation Powder
Time Frame: 11 days
|
11 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The time-matched change from baseline in QTc after therapeutic dose Technosphere® Inhalation Powder based on an individual correction (QTcI) method.
Time Frame: 11 days
|
11 days
|
The maximum change in time-matched, placebo-subtracted QT interval corrected by Fridericia formula (QTcF) and Bazett formula (QTcB), respectively, for supratherapeutic dose of Technosphere® Inhalation Powder.
Time Frame: 11 Days
|
11 Days
|
The maximum change in time-matched, placebo-subtracted QT/QTc intervals by Fridericia formula (QTcF), and by Bazett formula (QTcB), respectively, for therapeutic dose of Technosphere® Inhalation Powder.
Time Frame: 11 Days
|
11 Days
|
Change in ECG morphological patterns
Time Frame: 11 Days
|
11 Days
|
Heart rate and RR interval.
Time Frame: 11 Days
|
11 Days
|
PR interval.
Time Frame: 11 Days
|
11 Days
|
QRS interval.
Time Frame: 11 Days
|
11 Days
|
Correlation between the QTcI change from baseline and plasma concentrations of FDKP.
Time Frame: 11 Days
|
11 Days
|
Plasma concentrations of FDKP.
Time Frame: 11 Days
|
11 Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (ACTUAL)
August 1, 2008
Study Completion (ACTUAL)
October 1, 2008
Study Registration Dates
First Submitted
July 22, 2008
First Submitted That Met QC Criteria
July 22, 2008
First Posted (ESTIMATE)
July 24, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
June 13, 2012
Last Update Submitted That Met QC Criteria
June 12, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MKC-T-131
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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